THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM

K992898 · Bright Medical Instruments · GZT · Oct 21, 1999 · Neurology

Device Facts

• Record ID: K992898
• Device Name: THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
• Applicant: Bright Medical Instruments
• Product Code: GZT · Neurology
• Decision Date: Oct 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4800
• Device Class: Class 2

Intended Use

To provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the retractor, down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which a microscope and surgical instruments can be manipulated.

Device Story

Dilation Retractor System provides minimally invasive spinal access. System includes series of dilators, tubular retractors of various lengths, and guide wire. Device placed down to lamina; attached to flexible arm for self-locking access to spinal site. Used in OR by neurosurgeons during discectomy procedures. Provides stable surgical corridor for microscope and instrument manipulation. Benefits patient via minimally invasive approach.

Clinical Evidence

No clinical data. Performance data based on bench testing confirming the device functions in a safe and effective manner comparable to the predicate.

Technological Characteristics

System consists of dilators, tubular retractors, and guide wire. Manufactured from materials equivalent to the predicate device. Mechanical, non-powered, non-implantable surgical instrument.

Indications for Use

Indicated for providing a self-locking device to hold the edges of a wound open for neurosurgical procedures.

Regulatory Classification

Identification

A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

Predicate Devices

• Sofamor Danek MicroEndoscopic Discectomy Retractor System

Submission Summary (Full Text)

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OCT 21 1999

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Page 10

K992898

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# SECTION 6

# 510(k) SUMMARY

| Submitter's Name: | Bright Medical Instruments |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 799 N.E. 71st Street<br>Boca Raton, Florida 33467 |
| Contact Person: | Robert E. Simonson |
| Telephone: | 877-527-4448 |
| Facsimile: | 561-998-8224 |
| Date Prepared: | July 30, 1999 |
| Device Trade Name: | Dilation Retractor System |
| Device Common Name: | Surgical Retractor |
| Classification Name: | Self-Retaining Retractor for Neurosurgery |
| Predicate Device: | Sofamor Danek MicroEndoscopic<br>Discectomy Retractor System |
| Device Description: | Series of dilators, tubular retractors of<br>various lengths and guide wire for use in<br>providing access to the spine for<br>minimally invasive discectomy<br>procedures. |
| Intended Use: | To provide the surgeon with minimally<br>invasive surgical access to the spine by<br>ensuring the placement/positioning of the<br>retractor, down to the lamina, with its<br>attachment to a flexible arm to provide a<br>self locking method of access to the<br>spinal site through which a microscope<br>and surgical instruments can be<br>manipulated. |

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| Technological Characteristics<br>and Comparison to Predicate | The Bright Medical Dilation Retractor<br>System is manufactured from equivalent<br>materials, with similar dimensions, to<br>achieve the same surgical objectives as<br>the predicate MED MicroEndoscopic<br>Discectomy System. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | When used as designed, the Dilation<br>Retractor System functions in as safe<br>and effective a manner as the predicate<br>device. |
| Conclusion: | The Bright Medical Dilation Retractor<br>System is safe and effective and is<br>substantially equivalent to the predicate<br>device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Mr. Robert E. Simonson President Bright Medical Instruments 799 North East 71st Street Boca Raton, Florida 33487

Re: K992898

> Trade Name: Bright Medical Dilation Retractor System Regulatory Class: II Product Code: GZT Dated: July 29, 1999 Received: August 27, 1999

Dear Mr. Simonson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Robert E. Simonson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Page 9

# K992898

#### SECTION 5

### INDICATIONS FOR USE

#### Bright Medical Dilation Retractor System

Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.

Prescription Use __

or

Over the Counter _______________

Poole Jo

(Division Sign-Off) Division of General Restorative Devices 128 510(k) Number